Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:19 AM
Ignite Modification Date: 2025-12-26 @ 3:20 AM
NCT ID: NCT00939120
Description: Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
Frequency Threshold: 5
Time Frame: 19 months.
Study: NCT00939120
Study Brief: Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tolterodine ER 4mg + Dutasteride 0.5mg Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily. None None 4 23 21 23 View
Placebo + Dutasteride 0.5mg Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily. None None 5 23 22 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transient ischemic attacks SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasal airway obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cervical stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oral thrush SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Schatzki ring SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Suicidal self-inflicted gunshot wound, lethal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gastropathy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gallstones SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Mass on kidney SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Presbyesophagus, dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hiatal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epistaxis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Difficulty urinating SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency / incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URI / sinusitis / rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Bronchitis / pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Plantar fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Actinic keratosis, basal cell carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increase in prostate specific antigen SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Prostate nodule SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cataracts SYSTEMATIC_ASSESSMENT Eye disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Groin pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Kidney stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View